Identification of Biomarkers Associated With the Presence of Malignant Pancreatic Lesions Compared to Benign Lesions.

Not Applicable

Recruiting

• Conditions: Benign Pancreatic Lesion
• Interventions: Other: Biological sample

• Registration Number: NCT06397846
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

The challenge for medical oncology is to develop plasma biomarkers that can detect the influence of the stroma on diagnosis, prognosis and response to chemotherapy.

Today, there is no validated blood test to help diagnose pancreatic cancer (PDAC). The search for blood biomarkers of the tumor stroma and immunological markers is therefore a major challenge in orienting the diagnosis towards PDAC and optimizing the therapeutic management of pancreatic cancers.

The aim of the study is to identify biomarkers associated with the presence of malignant pancreatic lesions (patients from the Pancreas-CGE cohort, a cohort already set up by our team) compared with benign lesions (patients followed up for benign pancreatic lesions). Candidate biomarkers from our preliminary work will be considered initially. Other biomarkers may be explored secondarily.

The ultimate goal is to develop a clinico-biological signature that is as efficient as possible in predicting the presence of malignant pancreatic lesions compared with benign ones.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-30
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-03
• Status Verified: 2024-12
• Study Start: 2024-12-11
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Men and women ≥18 years
• Patient followed for benign pancreatic lesions:

chronic pancreatitis acute pancreatitis at a distance from the acute episode (> 4 weeks) with indication for echo-endoscopy for suspected precancerous pancreatic lesions (PanIN, TIPMP, mucinous cystadenomas) or other cystic lesions (serous cystadenomas)

Exclusion Criteria

• Malignant pancreatic tumor
• Legal incapacity or limited legal capacity

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biological sample	Biological sample	Blood sample

Primary Outcome Measures

Name	Time	Method
the malignant versus benign nature of the pancreatic lesion, based on radiological, echo-endoscopic and/or anatomopathological characteristics.	one visit at baseline

Trial Locations

Locations (2)

University Hospital of Besancon; 🇫🇷 Besançon, France

Hôpital Nord Franche-Comté; 🇫🇷 Montbéliard, France